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临床试验/NCT05743608
NCT05743608已完成不适用

Non-interventional, Open-label, Prospective Study to Assess the Effectiveness of BDP/FF/G Fixed Triple Inhalation Powder on Symptom Scores in Moderate to Severe COPD Patients, Uncontrolled With Inhaled Dual Therapies (LABA/LAMA or ICS/LABA)

Chiesi Hungary Ltd.39 个研究点 分布在 1 个国家目标入组 1,336 人开始时间: 2023年3月29日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
1,336
试验地点
39
主要终点
COPD Assessment Test (CAT)

研究概览

简要总结

The goal of this observational study is to measure improvement in health related quality of life in moderate to severe COPD patients treated with Trimbow inhalation powder. The main question[s] it aims to answer are:

  • Treatment's effect on quality of life
  • Treatment's effect on lung function Participants will be assessed according to routine clinica practice, without any additional intervention.

详细描述

COPD is a severe and very common disease affecting a large proportion of smokers (and even non-smokers) all around the world. With the large prevalence and wide spectrum of disease presentation (from limited obstruction to life threatening conditions) there is a need for differentiated, targeted approach to therapy. For this purpose, plenty of inhaler devices had been developed. Chiesi is the only company which provides fix triple combinations in both DPI and pMDI formulations. While there is ample data from multiple studies on the real-world effectiveness of the pMDI, there is a relevant gap in our knowledge on the RWE effectiveness of the DPI device Trimbow dry powder inhaler is a novel extrafine, single inhaler triple therapy, in a state of the art dry powder inhaler, which is easy to use and may provide additional benefit to a large proportion of COPD patients. However, there are only a limited number of studies assessing its effectiveness, especially in patients with moderate airflow obstruction. Providing more real-world evidence that Trimbow® dry powder inhaler is an effective and preferred treatment option in reducing symptoms and improving lung function in all COPD patients, would help pulmonologists choose the most suitable treatment option for a very wide array of patients.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
35 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

COPD Assessment Test (CAT)

时间窗: 6 months

Change in symptom scores (COPD Assessment Test - CAT) after six months of treatment. On a scale of 0-40

次要结局

  • Responders(6 months)
  • Health Related Quality of Life (HRQoL) - questions(6 months)
  • Symptoms(6 months)
  • Saturation(6 months)
  • HRQoL - VAS(6 months)
  • Night-time symptoms(6 months)
  • mMRC(6 months)
  • Lung function - Forces Expiratory flow in 1 second (FEV1)(6 months)
  • Lung function Forced Vital Capacity (FVC)(6 months)
  • Adherence(6 months)

研究者

发起方
Chiesi Hungary Ltd.
申办方类型
Industry
责任方
Sponsor

研究点 (39)

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